Brief Summary

The purpose of this study is to explore the effect of the collaborative health management model on the functional status, quality of life and rehospitalization rate of patients with heart failure. This is a three-year project. The first phase (introduction phase): A systematic literature review and meta-analysis of collaborative care and heart failure patients will be conducted, and relevant research results will be evaluated for the clinical benefits of heart failure patients, and empirical knowledge will be proposed as The basic holistic conclusions are supported by the research literature on the establishment of a collaborative health management model for heart failure (CHMM). The second stage (construction period): based on the results of systematic literature review and meta-analysis, adopt the CHMM model, design intervention measures, and conduct pilot studies to determine the safety and feasibility of the research, and review future research improvements Wherever possible, develop more complete intervention measures. The third stage (operation period): Randomized controlled trials were adopted, with random sampling and double-blind research design. In the cardiology ward of a regional teaching hospital in the south, 120 patients with heart failure who met the admission criteria were selected, and 60 patients were selected as control group. The group received routine care in the hospital, and 60 of the experimental group received interventions in the collaborative health management model. Data collection includes variables such as physiological indices, functional status, self-care behavior, quality of life, re-admission rate, medical cost. Instruments tools include Minnesota Heart Failure Quality of Life Questionnaire, European Heart Failure Self-care Behavior Scale after the intervention 1 month, 2 months, and 3 months.The intervention effect will be statistically verified and analyzed by GEE. It is hoped that this care model will be applied to the clinical care of patients with heart failure, and will be verified by clinical benefits, reduce symptom troubles, improve quality of life, and reduce medical costs.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

120

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Aug 2022

Geographic Reach

1 country

2 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

First Submitted

Initial submission to the registry

April 18, 2021

Completed

9 days until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed

1.3 years until next milestone

Study Start

First participant enrolled

August 6, 2022

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed

Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

1.3 years

First QC Date

April 18, 2021

Last Update Submit

August 6, 2022

Conditions

Heart Failure With Reduced Ejection Fraction (HFrEF)

Outcome Measures

Primary Outcomes (20)

CHF functional status
NYHAClass Ⅰ\~Ⅲ
pre intervenation
CHF functional status
NYHAClass Ⅰ\~Ⅲ
post intervention 1 months
CHF functional status
NYHAClass Ⅰ\~Ⅲ
post intervention 2 months
CHF functional status
NYHAClass Ⅰ\~Ⅲ
post intervention 3 months
CHF quality of life
Minnesota living with heart failure questionnaire, MLHFQ
pre intervention
CHF quality of life
Minnesota living with heart failure questionnaire, MLHFQ
post intervention 1 months
CHF quality of life
Minnesota living with heart failure questionnaire, MLHFQ
post intervention 2 months
CHF quality of life
Minnesota living with heart failure questionnaire, MLHFQ
post intervention 3 months
CHF rehospitalization
Re-admission rate
pre intervention
CHF rehospitalization
Re-admission rate
post intervention 1 months
CHF rehospitalization
Re-admission rate
post intervention 2 months
CHF rehospitalization
Re-admission rate
post intervention 3 months
CHF Self care behaviour
Heart Failure Self-Care Behaviour Sacle, EHFScBS
pre intervention
CHF Self care behaviour
Heart Failure Self-Care Behaviour Sacle, EHFScBS
post intervention 1 months
CHF Self care behaviour
Heart Failure Self-Care Behaviour Sacle, EHFScBS
post intervention 2 months
CHF Self care behaviour
Heart Failure Self-Care Behaviour Sacle, EHFScBS
post intervention 3 months
CHF Depression
Beck Depression Inventory(BDI)
pre intervention
CHF Depression
Beck Depression Inventory(BDI)
post intervention 1 months
CHF Depression
Beck Depression Inventory(BDI)
post intervention 2 months
CHF Depression
Beck Depression Inventory(BDI)
post intervention 3 months

Study Arms (2)

collaborative health management model program

EXPERIMENTAL

nursing education and self care program

Behavioral: collaborative health management model

Routine care

NO INTERVENTION

Tranditional education program

Interventions

collaborative health management modelBEHAVIORAL

nursing education program

collaborative health management model program

Eligibility Criteria

Age20 Years - 100 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

⑴Patients diagnosed as heart failure by specialists (NYHA Ⅰ-III); ⑵20 years of age or older; ⑶Patients with clear consciousness and no cognitive impairment and major diseases (such as cancer); ⑷Can communicate in Mandarin and Taiwanese; ⑸ Those who can answer the questionnaire by themselves or with the assistance of a research assistant.

You may not qualify if:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Antai Medical Care Corperation Antai Tian-Sheng Memorial Hospital/ Department of Nursing/National Talead

Study Sites (2)

Antai Medical Care Cooperation Antai Tian-Sheng Memorial Hospital

Pingtung City, Donggang Township, 928, Taiwan

NOT YET RECRUITING

Research team

Pingtung City, Taiwan

RECRUITING

Related Publications (1)

Chen CW, Wang TJ, Liu CY, Chuang YH, Su CC, Wu SV. Effectiveness of a nurse practitioner-led collaborative health care model on self-care, functional status, rehospitalization and medical costs in heart failure patients: A randomized controlled trial. Int J Nurs Stud. 2025 Feb;162:104980. doi: 10.1016/j.ijnurstu.2024.104980. Epub 2024 Dec 19.
PMID: 39709786DERIVED

Study Officials

Chih-Wen Chen
employer
STUDY CHAIR

Central Study Contacts

Chih-Wen Chen

CONTACT

886-8329966 onlylandy567@gmail.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Nurse Practitioner Leader

Study Record Dates

First Submitted

April 18, 2021

First Posted

April 27, 2021

Study Start

August 6, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

August 9, 2022

Record last verified: 2022-08

Locations

TW(2)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (20)

Study Arms (2)

collaborative health management model program

Routine care

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Locations